Brian Mccole Email & Phone Number

Greater Philadelphia Area

USDM is changing how compliance is addressed for life science companies worldwide. We are committed to achieving both PERFORMANCE and COMPLIANCE from the systems that run life sciences organizations. We partner with technology vendors who lead in the life sciences sector, assimilate the technology into a adaptable model and support the proper implementation and maintenance of such systems. Our partners include Agilent, Oracle and SAP as well as many others. Our clients include emerging biotechnology companies as well as the largest pharmaceutical players. Our team grows as quickly as we can find the rare people who can support our mission with the same passion and capability.

Philadelphia, Pa

Working with the Life Sciences industry to realize quality initiatives and compliance advancements ...

Subject Matter Expert - Quality & Enterprise Compliance at iGATE-Patni (formerly Taratec).

Quality consulting practice focused on the design, implementation, and valiidation of Quality Systems for ISO and GxP quality-regulated clients.

Program Manager for a global CSV/Part-11 remediation program as a response to client's Consent Decree. Managed the activities of 60+ consultants andc 100 GxP systems.

Managed ERP system implementations and validation projects for quality-related industures (i.e., GxP, ISO, Aerospace/Defense).